CDISC Standards Engineer & Data Governance Lead

IQVIA Argentina; Zaventem; On-site; EUR 65,000 - 90,000; Full time

Job summary

IQVIA in Belgium seeks an experienced CDISC standards specialist to shape end-to-end design and governance for SDTM/ADaM. You will collaborate with statisticians and programming teams to build global tools, drive compliance, and deliver timely regulatory submissions.

Ideal candidates have a CS/statistics background, strong communication, and 10+ years in SAS or related programming, with experience mentoring others in CDISC standards.

Qualifications

• Bachelor’s degree in computer science, statistics or related field.
• Experience with CDISC SDTM and ADaM.
• Experience on industry teams in CDISC/HL7/TransCelerate.
• Strong communication skills.
• 10 years SAS programming experience or similar languages; macro/subroutine development expected.
• Proficiency in two or more languages such as SAS, R, Python, Julia, C#, Java.

Responsibilities

• Support clients and IQVIA as an authority in the use of CDISC Standards through communication, collaboration, training, and mentorship.
• Partner with project statisticians and programming teams to develop global tools to support project programming needs in the use of CDISC Standards
• Lead the implementation of productivity tools for IQVIA and clients which improve compliance, efficiencies, and timeliness of deliverables to clients.
• Provide training and mentorship for the use of technology and systems, such as metadata repositories, to support IQVIA and client’s in their use.
• Assures that work delivered to clients meet minimum submission requirements as defined by FDA Guidance Documents and other regulatory guidance.
• Guide clients in their use of CDISC standards through governance teams.
• Monitors regulatory authority and standards organization sites for updates and informs IQVIA leadership of updates.
• Work on other IQVIA initiatives as a CDISC representative.
• Interact with various CDISC sanctioned teams in the development of standards.
• Represent IQVIA in the industry as a leader in the use of Standards and Automation
• Support leadership in the development of processes and tools which enable CDISC compliance.

Skills

CDISC Standards

Communication

SAS programming

Statistical programming

Mentoring

Education

Bachelor's degree in computer science, statistics, or related area

Tools

SAS

R

Python

Java

C#

Julia

Job description

IQVIA in Belgium seeks an experienced CDISC standards specialist to shape end-to-end design and governance for SDTM/ADaM. You will collaborate with statisticians and programming teams to build global tools, drive compliance, and deliver timely regulatory submissions.

Ideal candidates have a CS/statistics background, strong communication, and 10+ years in SAS or related programming, with experience mentoring others in CDISC standards.